Slide 1: Financial Results for Fourth Quarter and Fiscal Year End 2008 and Outlook for 2009
OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) Financial Results For Fourth Quarter and Fiscal Year End 2008 and Outlook for 2009 Committed to the development of new therapies that address unmet needs in the treatment of cancer
Slide 2: Forward-Looking Statements
Forward-Looking Statements This presentation contains forward-looking statements, including statements concerning anticipated clinical development activities, the potential benefits of product candidates and anticipated market opportunities. All statements other than statements of historical fact ar
Slide 3: Content for Today's Conference
Content for Today's Conference Update on current cash position and financial results Summarize the results of our phase 2 clinical trials for OGX-011 Present an update on our clinical development strategy for OGX-011 marketing approval Provide an update on our other product candidates which are curr
Slide 4: Financial Results
Financial Results Selected financial data - see 10-K for complete results
Slide 5: OGX-011: Lead Product Candidate
OGX-011: Lead Product Candidate Opportunity: Treatment resistant cancers including prostate, non- small cell lung, breast and various other solid tumors Target: Clusterin (cell survival protein) Mechanism of Action1: OGX-011 is designed to reduce the production of Clusterin which facilitates apoptos
Slide 6: Chemonaive CRPC Patients 1st Line Study Design
Chemonaive CRPC Patients Phase 2 Study in 1st Line Prostate Cancer: Study Design (randomized) R A N D O M I Z E Arm A Docetaxel (75 mg/M2 IV) q 21 days and OGX^011 (640 mg IV) weekly plus Prednisone (5 mg po bid) daily. Arm B Docetaxel (75 mg/M2 IV) q 21 days plus Prednisone (5 mg po bid) daily. Con
Slide 7: 1st Line Baseline Patient Characteristics
Phase 2 Study in 1st Line Prostate Cancer: Baseline Patient Characteristics Characteristic Arm A OGX-011 + Docetaxel N=40 Arm B Docetaxel N=41 Total N=81 Median Age (Range) 68 (54-84) 69 (49-87) 69 (49-87) ECOG PS 0:1 21:19 20:21 41:40 PSA >5-20 >20-100 >100 6 14 20 8 12 21 14 26 41 Sites of Metasta
Slide 8: 1st Line CRPC: Favors OGX-011 + Docetaxel
Phase 2 Study in 1st Line Prostate Cancer: Favors OGX-011 + Docetaxel 1st Line CRPC 1 1st Line CRPC 1 OGX-011 + docetaxel Arm A Docetaxel Arm B Median Survival 2, 3 27.5 months 16.9 months Median Number of Treatment Cycles Received 8 cycles 6 cycles Early Discontinuation of Chemotherapy (within 3 mo
Slide 9: 1st Line Reasons For Treatment Discontinuation
Phase 2 Study in 1st Line Prostate Cancer: Reasons For Treatment Discontinuation Reasons for Off Study OGX-011 + Docetaxel Docetaxel OGX-011 + Docetaxel Docetaxel Death 0 2 PSA Progression 2 6 PSA and Objective disease progression 2 3 Objective disease progression 3 6 Symptomatic progression 1 0 Int
Slide 10: OGX-011 Knock-down of Serum Clusterin
Phase 2 Study in 1st Line Prostate Cancer: OGX-011 Knock-down of Serum Clusterin Percent Change from Baseline Day 8 Day 15 Day 1 C2 At PSA Response At PSA Progression - -25 - -20 - -15 - -10 0 5 10 Docetaxel + OGX-011 Docetaxel Evidence that OGX-011 treatment is affecting its target, clusterin, with
Slide 11: 1st Line Selected Adverse Events
Phase 2 Study in 1st Line Prostate Cancer: Selected Adverse Events1 ARM A OGX-011 + Docetaxel ARM A OGX-011 + Docetaxel ARM B Docetaxel ARM B Docetaxel GRADE % Any % 3 or 4 % Any % 3 or 4 Neutropenia 93 73 80 63 Lymphopenia 90 53 68 20 Hemoglobin 93 0 93 7 Platelets 30 3 20 0 Creatinine 30 3 10 0 AS
Slide 12: 2nd Line Study Design (Non-Comparative Study)
Median survival of 13 to15.8 months for 2nd Line docetaxel treatment with OGX-011 compared to reported median survivals of ~ 10 months in 2nd Line treatment of CRPC Ongoing Phase 2 Study in 2nd Line Prostate Cancer: Study Design (Non-Comparative Study) R A N D O M I Z E Arm A Docetaxel (75 mg/M2 IV)
Slide 13: 2nd Line Baseline Patient Characteristics
Phase 2 Study in 2nd Line Prostate Cancer: Baseline Patient Characteristics Mitoxantrone & OGX-011 (n=22) Docetaxel & OGX-011 (n=20) Docetaxel & OGX-011 (n=45) Median # of Cycles of 1st-line Treatment (Range) 10 (2-22) 10 (2-18) 10 (2-29) ^30% Decline in PSA with 1st-line Treatment (%) 73% 75% 76% M
Slide 14: 2nd Line Summary of Selected Data
Phase 2 Study in 2nd Line Prostate Cancer: Summary of Selected Data 2nd Line CRPC 2nd Line CRPC 2nd Line CRPC 2nd Line CRPC 2nd Line CRPC OGX-011 + docetaxel Docetaxel2 Docetaxel3 OGX-011 + Mitoxantrone1 Mitoxantrone2 Median Survival 13 -15.8 mo 1 ~ 10 mo. 9.6 mo. 11.4 mo. ~ 10 mo. Median Number of
Slide 15: 48% Pain Palliation in OGX-011 Plus Docetaxel Retreatment
Phase 2 Study in 2nd Line Prostate Cancer: 48% Pain Palliation in OGX-011 Plus Docetaxel Retreatment Durable pain responses of 12 weeks (84 days) or greater = 44% NOTE: 27 of the 45 patients (60%) treated with OGX-011 plus docetaxel retreatment entered the study with prostate cancer-related pain ? o
Slide 16: Serum Clusterin Levels During OGX-011 Treatment Predictive of Survival
Phase 2 Study in 2nd Line Prostate Cancer: Serum Clusterin Levels During OGX-011 Treatment Predictive of Survival The curves differ significantly (log-rank p = 0.0003)
Slide 17: Evidence of Restoring Docetaxel Sensitivity with OGX-011
Time (2 weeks per mark) Phase 2 Study in 2nd Line Prostate Cancer: Evidence of Restoring Docetaxel Sensitivity with OGX-011 Patient: 025-011
Slide 18: 1st Line Non Small Cell Lung Cancer: Study Design
Chemonaive Stage IIIB/IV NSCLC Patients Phase 2 Study in 1st Line Non Small Cell Lung Cancer: Study Design S C R E E N I N G Arm A Gemcitabine (1250 mg/M2 IV) days 1 and 8 and either Cisplatin (75 mg/M2 IV) or Carboplatin (AUC 5) day 1 plus OGX^011 (640 mg IV) weekly. Continue treatment for up to 6
Slide 19: 1st Line NSC Lung Cancer: Baseline Patient Demographics
Characteristic N = 81 Age (median) (range) (yrs): 61 (43-79) Gender: Male 51% Female 49% Stage: IIIB 18% IV 82% Histology: Adenocarcinoma 51% Squamous Cell 16% Undifferentiated/Unspecified 33% Median time since diagnosis (mos): 2 (0-54) ECOG Score at screening: 0 32% 1 68% Phase 2 Study in 1st Line
Slide 20: 1st Line NSC Lung Cancer: Improved Survival with OGX-011 vs. Published Studies
Phase 2 Study in 1st Line NSC Lung Cancer: Improved Survival with OGX-011 Treatment vs. Published Studies Results as of January 23, 2009 Median Follow-up 33 months Number of Patients Alive 16/81 (20%) Median Progression-Free Survival (range) 4.6 months (0.06-15.6) Median Overall Survival 14.1 months
Slide 21: FDA Highlights for OGX-011 in 2008
FDA Highlights for OGX-011 in 2008 SPA approved with FDA for Phase 3 trial of OGX-011 evaluating overall survival in 2nd-line docetaxel treatment of CRPC Fast Track designation received from FDA for the development of OGX-011 FDA agreement that durable pain palliation is an acceptable and desirable
Slide 22: Clinical Development Strategy for Approval
Clinical Development Strategy for Approval Clinical Development Strategy is to obtain the following indication: OGX-011 in combination with docetaxel chemotherapy is indicated for the treatment of metastatic CRPC There are three possible Phase 3 trials that would provide evidence of safety and effic
Slide 23: OGX-427: Clinical Pipeline Highlight
OGX-427: Clinical Pipeline Highlight Target/Opportunity: Heat shock protein 27 (Hsp27) / Treatment resistant cancers including prostate, breast, lung, ovarian, bladder, pancreas, multiple myeloma, and others Mechanism of Action1: OGX-427 reduces Hsp27 levels and facilitates apoptosis by: Increasing
Slide 24: Other Pipeline & Corporate Highlights in 2008
Other Pipeline & Corporate Highlights in 2008 SN2310 Completed Phase 1 clinical trial. Dose-limiting toxicity defining the MTD in this heavily pretreated study population was significant neutropenia. OGX-011 OncoGenex increased its interest in OGX-011 through an amended development agreement with IS
Slide 25: Key Objectives for 2009
Key Objectives for 2009 ASCO 2009 Report final data from the randomized Phase 2 trial evaluating OGX-011 with 1st-line docetaxel treatment in CRPC Q2 2009 Complete SPA agreement with FDA on the design of a second Phase 3 registration trial evaluating durable pain palliation with 2nd-line docetaxel t
Slide 26: OncoGenex Pharmaceuticals, Inc.
OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) Committed to the development of new therapies that address unmet needs in the treatment of cancer